Identify process deviations, abnormalities, or drift; document observations and escalate issues in a timely manner.
Provide day‑to‑day technical support to Manufacturing Operations related to downstream process execution.
Act as operational process SME for assigned downstream unit operations, supporting safe, compliant, and consistent process performance.
Support updates to downstream SOPs, batch records, and process documentation related to new or modified processes.
2. Downstream Process Robustness & Performance
Support routine review and trending of downstream process data to identify variability, recurring issues, or opportunities for improvement.
Support implementation of process improvements aimed at enhancing robustness, yield, consistency, or operational reliability.
Collaborate with MSAT and Automation teams to support effective use of digital tools and process data
3. Support to New Product Introduction (NPI) & Startup (Limited Scope)
Support NPI and process startup activities as assigned, such as
Execution support during engineering runs, PPQ, or startup manufacturing
Process data collection, verification, and documentation
Support of process readiness and operational handover activities
Participate in downstream process risk assessments (e.g. FMEA) by gathering information and supporting action tracking.
Support updates to downstream SOPs, batch records, and process documentation related to new or modified processes.
4. Deviation, Investigation & CAPA Support
Participate in process related deviations and investigations
Escalate complex issues to Senior Engineers in a timely manner.
5. GMP, Safety & Compliance
Perform assigned activities in compliance with GMP, EHS, and site requirements.
Support audit and inspection readiness through accurate and timely documentation.
6. Continuous Improvement
Identify and propose improvement opportunities related to downstream process robustness, control, or execution.
Participate in OE / Lean / continuous improvement initiatives focused on downstream manufacturing processes.
About You
Knowledge, Skills & Competencies
Basic understanding of downstream biopharmaceutical processes (e.g. seed train, cell culture, bioreactor operations, multi-column chromatography, viral inactivation).
Working knowledge of GMP requirements and process data integrity principles.
Basic data analysis and trending capability to support process performance monitoring.
Able to work effectively within cross‑functional teams with appropriate guidance.
Demonstrates structured problem‑solving and analytical thinking.
Good technical writing and communication skills.
Strong team player with a continuous learning mindset.
Qualifications / Requirement
Diploma or Bachelor’s degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Life Sciences, or related discipline.
3–4 years of experience in downstream biopharmaceutical manufacturing, process support, or manufacturing operations in a regulated environment.
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
